FDA Approves First New Treatment for Fibromyalgia in Over 15 Years: Daily Dose

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On August 15, 2025, we reported on the US FDA approval of cyclobenzaprine hydrochloride sublingual tablets (Tonmya; Tonix Pharmaceuticals) for the treatment of fibromyalgia in adults.

The approval

Tonmya, previously known as TNX-102 SL, is a first-in-class, non-opioid, once-nightly analgesic formulated for sublingual administration, designed for rapid absorption and reduced production of the long half-life metabolite norcyclobenzaprine.

The FDA based its decision on efficacy data from 2 pivotal phase 3 randomized, double-blind, placebo-controlled trials (RELIEF and RESILIENT), which enrolled nearly 1000 adults with fibromyalgia. In both studies, participants receiving Tonmya experienced significantly greater reductions in daily pain intensity scores over 14 weeks compared with placebo. A higher proportion of patients in the active-treatment group also achieved at least a 30% improvement in pain.

Safety findings across 3 phase 3 trials (n >1400) indicated that Tonmya was generally well tolerated. The most common adverse events (incidence ≥2% and higher than placebo) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

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